(22 days)
Nobel Biocare's Procera® Abutment Brånemark is indicated for the treatment of partially edentulous patients requiring a prosthetic device. In addition to the Brånemark implant, the abutment's hexagon connector fits the external hexagon of the following endosseous implants:
- 3i® 3.75
- Lifecore® Biomedical Restore 3.75
- Zimmer® Dental Taperlock 4.0
- Sterngold Implamed® 3.75
The Procera® Abutment Brânemark is an artificial tooth abutment designed to fit and function on root-form endosseous implants having an external hexagon abutment interface.
Nobel Biocare's Procera® Abutment Brånemark is intended for use in the treatment of partially edentulous patients in arder to restore chewing function. The Procera® Abutment Brånemark is a prosthetic device panonto in brace's Brånemark external hexagon endosseous implant as well as the endosseous implants specifically indicated. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Brånemark can be made from titanium, alumina, or zirconia.
The provided text is a 510(k) summary for the Nobel Biocare Procera® Abutment Brånemark. It details the device description, indications for use, and a statement that "The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Class II Special Controls Guidance Document: Root Porn Lindoseous Beach (May 12, 2004) was identified as applicable to this submission."
However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.
The document is a regulatory submission for a dental implant abutment, focused on demonstrating substantial equivalence to previously marketed devices. It does not include the type of performance study details requested in your prompt.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)